NCT01276730

Brief Summary

The study objective:

  • To evaluate the response and survival rates after treating stage III cervical cancer with retinoic acid and interferon-α combined with radiotherapy in the study group.
  • To evaluate the response and survival rates after treating stage III cervical cancer patients with concomitant cisplatin and radiotherapy in the control group.
  • To evaluate the safety and tolerability of the combination of retinoic acid, interferon-α and radiation therapy compared with concomitant chemo-radiation therapy.
  • To determine if there is an immune response to Human Papillomavirus (HPV) by estimating serum IgG1 and IgG2 antibodies against E7 proteins of HPV types 16 and 18 before and after treatment. The study hypothesis:
  • The response rates and survival rates of retinoic acid and interferon-α combination with radiation will be better than chemo-radiation to treat stage III cervical cancer.
  • Treatment with the retinoic acid, interferon-α and radiation combination therapy will be less toxic and better tolerated than chemo-radiation therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

7.8 years

First QC Date

November 2, 2010

Last Update Submit

December 27, 2017

Conditions

Cervical Cancer

Keywords

Advanced cervical cancerIndia

Outcome Measures

Primary Outcomes (1)

  • Survival

    Overall survival curves will be computed using the method of Kaplan and Meyer. The difference in survival between the two groups will be compared by log rank test with the O'Brien-Fleming boundaries to control for alpha spending at a planned interim analysis (50% of the total accrual).

    3 years or death

Secondary Outcomes (3)

  • Response rate

    3 years or death

  • Overall toxicity

    3 years or death

  • Determine immune response to Human Papillomavirus HPV

    3 years to death

Study Arms (2)

Group A

EXPERIMENTAL

Treatment consists of Interferon, given as a sub-cutaneous injection, 3 times per week for 4 weeks, 20 mg Retinoic Acid tablets, 2 times a day for 30 days. starting from the first day of radiation.

Drug: Interferon, Retinoic Acid and radiation

Group B

ACTIVE COMPARATOR

Treatment consists of radiation and chemotherapy using Cisplatin. Cisplatin, given intravenously, will be administered on the first day of each week, mixed with saline solution, before and after the Cisplatin infusion. Radiation will be given for a few minutes daily, five days a week, for approximately 5 weeks. Two weeks after completion of external radiotherapy, subject will receive internal radiation (brachytherapy) once a week for two weeks. For this internal radiation a specially designed instrument will be inserted into the vagina that will be connected to a machine for a few minutes.

Drug: Cisplatin and radiation

Interventions

Interferon, Retinoic Acid and radiationDRUG

Interferon-α2b will be administered 3 times a week for four weeks at a dose of 3 x 106 IU subcutaneously concomitant with radiotherapy. The first dose will be administered on the day the subject starts radiotherapy; 13-cis-retinoic acid will be administered orally at a dose of 40 mg/day for 1 month starting from day 1 of radiotherapy; a total of 40 to 45 Gy whole pelvis irradiation will be delivered in conventional fractions to both the study group and the control group. Additional parametrial dosages will be delivered to complete 55 Gy. This will be followed by two intracavitary applications of approximately 40-50 Gy, depending on the volume.

Group A
Cisplatin and radiationDRUG

Weekly cisplatin will be administered concurrent with external beam radiation at a dose of 40mg/m2/week for 5 weeks; a total of 40 to 45 Gy whole pelvis irradiation will be delivered in conventional fractions. Additional parametrial dosages will be delivered to complete 55 Gy. This will be followed by two intracavitary applications of approximately 40-50 Gy, depending on the volume.

Group B

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced cervical cancer

You may not qualify if:

  • Previously treated for cancer of the cervix
  • Karnofsky Performance Score less than 50
  • Renal dysfunction ( Serum creatinine \> 2.0mg/dl)
  • Hepatic dysfunction (Serum bilirubin\> 2.0 mg/dl, transaminases \> 1.5 times normal)
  • Pregnant or lactating women: Women will be tested by pregnancy test for possibility of existing pregnancy. Those that meet criteria of trial will be asked to promise that they don't become pregnant; barrier contraception will be recommended.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chittaranjan National Cancer Institute

Kolkata, 700026, India

Location

Related Publications (1)

  • Basu P, Jenson AB, Majhi T, Choudhury P, Mandal R, Banerjee D, Biswas J, Pan J, Rai SN, Ghim SJ, Miller D. Phase 2 Randomized Controlled Trial of Radiation Therapy Plus Concurrent Interferon-Alpha and Retinoic Acid Versus Cisplatin for Stage III Cervical Carcinoma. Int J Radiat Oncol Biol Phys. 2016 Jan 1;94(1):102-110. doi: 10.1016/j.ijrobp.2015.09.040.

    PMID: 26700705DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

InterferonsTretinoinRadiationCisplatin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalPhysical PhenomenaChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Partha S Basu, MD

    Chittaranjan National Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2010

First Posted

January 13, 2011

Study Start

October 1, 2007

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 29, 2017

Record last verified: 2017-12

Locations

IN(1)