India hospital network launched to initiate life-saving colon cancer trial

New Delhi: Cancer surgery experts have launched a network of hospitals across India to support a country-wide clinical trial exploring how giving colon cancer patients’ chemotherapy before surgery cuts their risk of the disease coming back.

The Cancer Research UK-funded FOxTROT trial showed that patients who had chemotherapy before surgery were significantly less likely to see their cancer come back, compared with those who got all their chemotherapy after surgery.

Led by expert cancer specialists in India, supported by Universities of Birmingham and Leeds, FOxTROT-Global is a pilot study, being run from India, in parallel to the on-going FOxTROT2 trial open in the UK and France – allowing experts to look at the feasibility and safety of conducting a subsequent full trial in Indian patients.

Launched at G B Pant Hospital, in Delhi, 12 hospitals across India including Tata Memorial Hospital Mumbai, and Tata Medical Centre Kolkata have proposed to be part of the FOXTROT-Global as part of the FOxTROT2 Global trial – an international trial running in parallel in multiple countries across the world.

Dion Morton, Professor of Surgery at the University of Birmingham said: “Colon cancer is the fourth most common cancer worldwide and accounts for 10% of cancer deaths worldwide. Whilst treatment can cure half of affected patients, many older and frailer patients still die from the disease. Chemotherapy before surgery is a safe treatment option that could be life saving for thousands of patients.

“Post-operative chemotherapy is sometimes not considered beneficial for frail patients because of the adverse side effects, but providing a shorter course of chemotherapy before surgery would overcome many obstacles. We believe that frailer or older patients, may benefit from this novel approach.”

Reducing colon cancer returning

1,053 colon cancer patients from 85 hospitals in the UK, Denmark and Sweden were involved in the initial FOxTROT trial, also led by scientists at Birmingham and Leeds. The researchers discovered that delivering chemotherapy before surgery reduced the chance of colon cancer returning within two years by 28%.

The scientists believe that giving chemotherapy to bowel cancer patients before surgery could be easily adopted in India and other health systems across the world, with over 10,000 patients every year in India alone who could benefit from this treatment.

The study will be co-ordinated by experts at the NIHR Global Surg India Hub – based at Ludhiana – part of a global surgical research network funded by the UK’s National Institute for Health Research (NIHR) and led by the University of Birmingham with Hubs in Benin, Ghana, India, Mexico, Nigeria, Rwanda and South Africa.

Dr Laura Magill, Associate Professor at the Birmingham Clinical Trials Unit at the University of Birmingham said: “Up to 1 in 3 colon cancer patients can see their cancer come back after surgery. That figure is far too high and we need new treatment strategies to stop colon cancer coming back.

“The standard approach has been to give chemotherapy after surgery to eradicate any cancer cells that might have spread before surgery, but our research shows that giving some of that chemotherapy before surgery increases the chances that all cancer cells will be killed.

“A growing body of evidence is showing the value of pre-operative chemotherapy in several other cancers, and we believe that our results could transform how we approach colon cancer in the clinic.”

FOxTROT 2 India may provide much needed, high-quality randomised data to evaluate whether a larger trial is needed. A key consideration for FOxTROT-Global is patient selection and deciding which patients are older or frail. The most likely participants will be patients with advanced operable colon cancer likely to require post-surgical chemotherapy, but who not be suitable to receive or unlikely to complete such treatment chemotherapy due to frailty or comorbidities.

University of Birmingham Chancellor Lord Bilimoria commented: “The work of Professor Morton, his team and partners in the UK and India will potentially benefit many thousands of cancer patients across India and beyond. This is truly a shining example of how working in partnership between the UK and India can help us to achieve magnificent outcomes that can improve the lives of people around the globe and save many lives.”

This study is led by CMC Ludhiana, PSG Hospitals Coimbatore, and TMC Kolkata. Dr K S Rajkumar, from PSG Super Specialty Hospital, Coimbatore, commented: “The results from the recently published FOxTROT study show that chemotherapy given before surgery improves success rate in patients with advanced bowel (colon) cancer. This is a significant new advancement in the treatment of bowel cancer patients.

“Colorectal cancers are the sixth most common cancer in India and are increasingly becoming common in India with an estimated 65,000 new cases every year, mostly due to the westernisation of our diet. However, the profile of bowel cancer patients in India is different when compared to Western countries in that they are younger and present in more advanced stages.

“We also do not have a national bowel cancer screening programme India. Therefore, we need to check whether the same approach of giving chemotherapy before surgery will benefit Indian bowel cancer patients. For this, we are planning a pilot study across 10 leading cancer centres across India called FOxTROT-INDIA.”

Matthew Seymour Professor of Gastrointestinal Cancer Research at the University of Leeds said: “Timing is everything when it comes to treating colon cancer. The simple act of bringing forward chemotherapy, giving it before instead of after surgery, delivers some remarkable results. Scaling up this treatment worldwide, including in low and middle income countries, could transform cancer care and save many thousands of lives.”