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Concomitant Chemo-radiation in Advanced Stage Carcinoma Cervix: A Phase III Randomized Trial

Phase 3
18 Years
65 Years
Open (Enrolling)
Cancer of Cervix

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Trial Information

Concomitant Chemo-radiation in Advanced Stage Carcinoma Cervix: A Phase III Randomized Trial

Carcinoma cervix is the commonest malignancy seen in Asian women and constitutes
approximately 30% of all cancers (1). It is also the leading cause of cancer mortality in
India. Nearly 50% of the patients present with advanced stages (FIGO Stage III/IV). The main
stay of treatment has traditionally been radical radiation therapy and over decades the
survival rates have achieved a plateau of 30 - 45% at 5 years. In developing countries the
socioeconomic problems, illiteracy, late presentation and irregular follow-up have further
compromised our survivals. Over the last decade there have been studies on the use of
chemo-radiotherapy in carcinoma cervix. Over 19 randomized trials have been published
addressing the issue of chemo-radiotherapy. However, heterogeneous data, poor randomization,
inadequate number of patients, sub-optimal radiotherapy, non-uniform use of chemotherapeutic
drugs, its sequencing and poor documentation have not yet provided the evidence to
substantially alter the practice. Hence, meta-analysis of these trials was undertaken to
further evaluate the role of chemo-radiotherapy in carcinoma cervix (2,3).

The first meta-analysis published by Cochrane Collaborative Group of 4580 randomized
patients (19 randomized trials) suggested that chemo-radiation did show an absolute survival
benefit improvement both in progression free and overall survivals by 16% and 12%
respectively (p<0.0001). The survivals were significantly better with Cisplatin based
concomitant chemo-radiation (p<0.0001). Incidentally, the distant metastasis rates were also
significantly lower in chemo-radiation (p<0.0001). However, all these benefits were seen
only in early stages. In addition, acute grade 3/4 hematological and gastro-intestinal
toxicities were higher with chemo-radiation (additional 8% and 5% respectively). The data
was insufficient to report on late toxicity (2).

The second meta-analysis of 9 randomized trials, recently published by the Canadian Group to
evaluate only cisplatin based concomitant chemo-radiation confirms the improvement in
overall survival (4year survival data) in advanced stages, bulky IB tumors (prior to
surgery) and high risk early disease (post-surgery). Although acute grade 3/4 hematological
and gastro-intestinal toxicities were higher in chemo-radiation, they were short-lived, with
only 2 deaths and the remaining resolved with medical treatment. There was no significant
increase in the late toxicity from the data available.

Both the Cochrane and Canadian meta-analysis have to a large extent tried to address the
role of concomitant chemo-radiation, but Carcinoma Cervix Stage III accounted for only
30-35% and moreover evaluation with optimal radiation schedules and comparison of late
toxicities still remains unanswered. What is more important is that the cisplatin is
relatively inexpensive and is available worldwide. This means that cisplatin-based
chemo-radiation is affordable in the developing countries where carcinoma cervix still forms
the major cancer. However, the role of chemo-radiation in Carcinoma Cervix Stage IIIB in a
developing countries including India still remains unexplored. We propose this randomized
study to evaluate the role and benefit of chemo-radiation in-patients with cervical cancer.

Inclusion Criteria:

- Histologically proven squamous carcinoma of cervix

- Performance index WHO grade 0 or 1

- Patients below 65 years of age


- Normal ECG and Cardiovascular system

- Normal hematological parameters

- Normal renal and liver function tests

Exclusion Criteria:

- Co-morbid conditions like medical renal disease

- Medical or Psychological condition that would preclude treatment

- H/o Previous treatment / Pregnancy

- Patient unreliable for treatment completion and follow-up.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To evaluate the single agent concomitant chemotherapy (Cisplatin) in Stage IIIB carcinoma cervix

Outcome Time Frame:

December 2008

Safety Issue:


Principal Investigator

Shyamkishore J Shrivastava, MD,DNB(RT)

Investigator Role:

Principal Investigator

Investigator Affiliation:

Professor & Head, Department of Radiation Oncology, Tata Memorial Hospital


India: Department of Atomic Energy

Study ID:




Start Date:

October 2003

Completion Date:

December 2011

Related Keywords:

  • Cancer of Cervix
  • Carcinoma Cervix
  • FIGO Stage IIIB
  • Radiation therapy
  • Chemoradiation
  • Treatment related toxicities
  • Cervical Cancer
  • Cervix Cancer
  • Carcinoma
  • Uterine Cervical Neoplasms