Postoperative Radiotherapy for Intermediate- and High-risk Patients With HNSCC Greater Than 6 Weeks After Surgery

Browse trials for

• Head and Neck Neoplasms 2,344

Keywords

• Radiotherapy
• Accelerated radiotherapy

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 75 is above the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Study arms

• Active comparator
  Conventional fractionation (5 Fractions)

  5 fractions per week, daily treatment Monday-Friday; dosage at the discretion of the treating radiation oncologist per standard of care

  Radiation: Conventional radiotherapy

• Experimental
  Accelerated fractionation (6 Fractions)

  6 fractions per week, daily treatment plus twice daily treatment for 1 day Monday-Friday; dosage at the discretion of the treating radiation oncologist per standard of care

  Radiation: Accelerated radiotherapy

Interventions

• RadiationAccelerated radiotherapy

  6 fractions per week, BID fractions one day per week

• RadiationConventional radiotherapy

  5 fractions per week, daily M-F

Primary outcomes

1. Locoregional Recurrence-free Survival

   Time to locoregional recurrence, will be assessed on an intention to treat basis using a one-sided log rank test to compare hazard rates between groups. Kaplan-Meier survival curves will also be generated with locoregional failure or death as the event of interest and last clinical disease assessment as a right-censor.

   Time frame: 2 years post radiotherapy

Secondary outcomes

1. Progression free survival (PFS)

   Progression-free survival will be calculated from the time of randomization to disease recurrence or death from any cause as the event and last follow-up as a right-censor. It will be compared between treatment arms.

   Time frame: up to 5 years

2. Overall survival (OS)

   Overall survival will be calculated from the time of randomization to death from any cause, with last follow-up as a right-censor.

   Time frame: up to 5 years

3. Acute and late toxicities

   Acute and late toxicities between each treatment arm will be measured by evaluating adverse events (AEs) by grade in each treatment arm. Using the Chi-square test (or Fisher's exact test if cell frequencies \<5) and a significance level of 0.05, comparisons will be made of the following outcomes between treatment arms: 1) the number of participants with at least one AE of grade 3 or higher, 2) the number of participants with grade 1 or higher toxicity, and 3) the number of patients with grade 3 or higher toxicity. Each of these analyses will result in the construction of 2x2 tables thus the use of the Chi-Square (or Fisher's exact test) will be appropriate. These analyses will be completed for both acute (between RT start and 90 days after RT) and late (more than 90 days after RT completion) toxicities.

   Time frame: up to 24 months post radiotherapy

4. Patient Report Outcomes (PRO) - PRO-CTCAE

   PRO-CTCAE measure of toxicity will be assessed by describing the counts and frequencies for the worst score observed in each participant in the whole cohort and by treatment arm. Using the Chi-square test (or Fisher's exact test if cell frequencies \<5) and a significance level of 0.05, a comparison will occur of the following outcomes between treatment arms: 1) the number of patients with at least one PRO-CTCAE score of grade 1 or higher, and 2) the number of patients with at least one PRO-CTCAE score of grade 3 or higher. These comparisons 1 and 2 will be completed for both acute (between RT start and 90 days after RT) and late (more than 90 days after RT completion) toxicities. The analysis of change in PRO-CTCAE score over time will also be performed using a likelihood-based Generalized Linear Mixed Model (GLMM) approach.

   Time frame: at baseline, end radiotherapy (RT), 3, 6, 12, and 24-months post RT

5. Patient Reported Outcomes (PRO) - MDASI-HN

   The MDASI-HN is a 28-item measure with three subscales: the 13 core MDASI items, 9 head and neck cancer-specific items, and 6 items specific to interference in daily life by the patient's symptoms. The change from baseline at each time point will be summarized using mean and standard deviation at end RT, 3, 6, 12, and 24-months post RT.

   Time frame: at End of Radiotherapy (RT), 3, 6, 12, and 24-months post RT

6. Nutritional Toxicity

   Nutritional toxicity will be measured by comparing the rates of reactive gastrostomy tube placement using a Fisher's exact test. For patients in whom a feeding tube is placed, the duration of tube will be defined as the time from tube placement to removal or last follow-up with a tube (right-censor) and will be estimated using the Kaplan-Meier method and compared between groups using the log-rank statistics.

   Time frame: up to 24 months post Radiotherapy

7. Time to initiation of Postoperative Radiotherapy (PORT)

   Time to initiation of PORT will be calculated as the number of days from date of primary curative resection (surgery date = day 0) to initiation of RT. This value will be compared between groups using a 2-sample t-test to see if there is a significant difference between groups on this covariate.

   Time frame: up to 16 weeks

8. Treatment package time

   The treatment package time will be calculated as the number of days from the primary surgical resection to the end of PORT (the last RT treatment for participants who complete therapy; for participants who do not complete the prescribed course of RT, this metric is moot) and compared between groups using a 2-sample T-test. The proportion of patients with treatment package time less than 100 days will be determined and compared between groups using the Chi-square test (or Fisher's exact test if cell frequencies \<5).

   Time frame: from surgical resection to end of PORT - up to approx. 165 days

9. Demographic characteristics of eligible participants

   The characteristics (age, gender assigned at birth, race, ethnicity) of potentially eligible participants will be described using count and frequency for categorical variables and mean (standard deviation) and median (range) for continuous variables. These factors will be compared between groups who do and do not enroll on study using the Chi-square tests for categorical and 2-sample t-tests for continuous measures. For participants who choose not to enroll, the reasons and rationale provided to support that decision will be described using count and frequency.

   Time frame: Prior to Radiotherapy (Pre-screening and baseline)

Individual participant data

Plan to share: No